This randomised, double-blind, low-dose comparator-controlled Phase 2b trial (n=87) will study the effects of different doses of psilocybin (PEX010; 1-10-25mg)delivered during a psilocybin-assisted psychotherapy (PAP) session in individuals with adjustment disorder following a cancer diagnosis.
The trial is sponsored by Psyence Australia Pty Ltd and conducted at Empax Centre in Leederville, Western Australia. It aims to assess the efficacy and safety of varying doses of PEX010 in alleviating anxiety symptoms linked to adjustment disorder (a stress response to a cancer diagnosis). Adults aged 18–80 with adjustment disorder due to a cancer diagnosis (and a life expectancy of at least six months) will be randomly assigned to one of three dosing groups. Each participant will undergo thorough preparatory sessions (some via telehealth) before a full-day, eight-hour dosing session on Day 14, followed by an integration session the next day. If participants do not respond by Week 10, they may receive a second PAP cycle at the 25 mg dose. The study includes follow-up visits through to three months after the final PAP cycle.
The primary outcome measures include changes in anxiety severity (as measured by the Hamilton Anxiety Rating Scale, or HAM-A) at Week 10 and the incidence of treatment-related adverse events, as well as monitoring suicidality using the Sheehan Suicide Tracking Scale (S-STS). This design helps determine both whether psilocybin therapy reduces anxiety and how safe it is across different doses.
Trial Details
Trial Number
Sponsors & Collaborators
Psyence GroupPsyence is pioneering the use of natural psilocybin for the long-term treatment of trauma and its mental health consequences.
Measures Used
Hamilton Anxiety ScaleThe Hamilton Anxiety Scale (HAM-A) was one of the first rating scales developed to measure the severity of anxiety symptoms and is still widely used today in both clinical and research settings.